Oral capsules are a well-known dosage form for administering various agents into the body. Generally speaking, such capsules have two basic components, namely, a fill material that includes a pharmaceutically active agent, and a shell that encapsulates the fill material. Upon administration, the fill material is released and absorbed by the body as the shell degrades under various digestive forces.
Many specific constituents have been used to form the shell of various capsule formulations. One basic component is a matrix, or film forming material, such as gelatin, hydroxypropyl methyl cellulose (HPMC), gums, or other polymeric materials including pullulan. Certain types of pullulan capsules are commercially available, for example, Capsugel NPcaps® capsules are available from Pfizer. Capsugel NPcaps® capsules contain pullulan, carageenan, and potassium chloride.
The present disclosure provides hard pullulan capsules that disintegrate more rapidly than Capsugel NPcaps® capsules in the oral cavity for the rapid delivery of pharmaceutical agents. The disclosure further provides aqueous pullulan film forming compositions with good setting properties to be used in the manufacture of hard capsules in a dip molding process, that disintegrate rapidly in the oral cavity.